Table 8.
Active clinical trials of mAbs that activate innate immunity in myeloid neoplasms.
| Disease type and inclusion criteria | Drug or drug combination, other therapies | Outcome measures | (Estimated) enrollment | Clinical trials identifier | Trial status |
|---|---|---|---|---|---|
| R/R AML R/R MDS |
Hu5F9-G4 (anti-CD47) | Primary: MTD, DLT, and AE | 40 | NCT02678338 | Recruiting (estimated completion mid 2018) |
| AML, MDS (R/R or de novo in patients not eligible for curative therapy) | Hu5F9-G4 vs. Hu5F9-G4 + AZA | Primary: AE and ORR | 96 | NCT03248479 | Recruiting (estimated completion mid 2022) |
| AML, MDS, other MPNs, NHL, HL, CLL, ALL, MM, solid tumors (all R/R) | TTI-621 (SIRPα-Fc) vs. TTI-621 + rituximab vs. TTI-621 + nivolumab | Primary: MTD, DLT, PK, and ORR | 270 | NCT02663518 | Recruiting (estimated completion mid 2019) |
| R/R AML High-risk MDS |
CC-90002 (anti-CD47) | Primary: MTD and DLT Secondary: ORR, PK, and ADA |
71 | NCT02641002 | Recruiting (estimated completion mid 2019) |
| R/R AML | Lirilumab (anti-KIRDL-1/2/3) + AZA | Primary: MTD and DLT Secondary: ORR |
37 | NCT02399917 | Active, not recruiting (estimated completion early 2020) |
| MDS | Lirilumab vs. lirilumab + AZA vs. lirilumab + nivolumab vs. lirilumab + AZA + nivolumab | Primary: ORR, CR, PR, and HI | 80 | NCT02599649 | Recruiting (estimated completion early 2025) |
| AML, high-risk MDS, CML, other MPNs, MM, HL, NHL, ALL (all after aHSCT) | Monalizumab (anti-CD94/NKG2A) | Primary: DLT Secondary: GvHD, NRM, CIR, DFS, and OS |
18 | NCT02921685 | Recruiting (estimated completion early 2019) |
AE, adverse events; aHSCT, allogeneic hematopoietic stem cell transplantation; ADA, anti-drug antibodies; AML, acute myeloid leukemia; AZA, 5-azacytidine; ALL, acute lymphoblastic leukemia; BP, blood parameters; CIR, cumulative incidence of relapse; CLL, chronic lymphocytic leukemia; CML, chronic myeloid leukemia; CR, complete remission; DFS, disease-free survival; DLT, dose-limiting toxicity; GvHD, graft-versus-host disease; HL, Hodgkin lymphoma; mAb, monoclonal antibody; MDS, myelodysplastic syndrome; MM, multiple myeloma; MPN, myeloproliferative neoplasm; MTD, maximum tolerated dose; NRM, non-relapse mortality; ORR, overall response rate; NHL, non-Hodgkin lymphoma; OS, overall survival; PK, pharmacokinetics; R/R, refractory/relapsed.
Data from http://ClinicalTrials.gov (Accessed: February 06, 2018).